Medical Device Manufacturer · US , Melville , NY

Olympus Medical Systems Corporation - FDA 510(k) Cleared Devices

81 submissions · 81 cleared · Since 2004

Recent clearances: Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D, Single Use Cytology Brush V (BC-V600P-3010), Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)

81

Total

81

Cleared

0

Denied

FDA 510(k) Regulatory Record - Olympus Medical Systems Corporation General & Plastic Surgery ✕

5 devices

1-5 of 5

Cleared Oct 07, 2025

Ultrasonic Bipolar Generator (USG-410)

General & Plastic Surgery · 90d

Cleared Aug 04, 2021

Ultrasonic Bipolar Generator USG-410 with accessories

General & Plastic Surgery · 51d

Cleared Jan 05, 2011

General & Plastic Surgery · 135d

Cleared May 26, 2006

LAPARO-THORACO VIDEOSCOPE XLTF-VAW

General & Plastic Surgery · 172d

Cleared Jun 03, 2005

OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG

General & Plastic Surgery · 57d